The AWH-IRB is a partner in the Protection of Human Research Participants.

The IRB is composed of a diverse group consisting of members with varied experience, expertise, and backgrounds, including:

Physicians

Pharmacists

Other health professionals

Administrators

Community members (not affiliated with Aspirus Wausau Hospital)

IRB members serve on a voluntary basis, for a two-year term, meeting once a month to review research for physicians & medical staff who are engaged in research.

The mission of the Institutional Review Board is to protect the rights and welfare of human research subjects. The IRB ensures that risks to subjects are minimized and reasonable in relation to the anticipated benefit, that selection of subjects is equitable, and that each subject is informed of the research and gives his/her consent prior to participation.

Research ­ reviewed by Aspirus Wausau Hospital IRB

If you or a loved one are interested in participating in a research study/trial or would like more information on the research being conducted in Wausau & surrounding communities that Aspirus Wausau Hospital IRB has reviewed please contact the following research facilities or the IRB Office.

Investigator Reference Manual & FAQ for Researchers

You may review the manual online or print it out. If you do not have access to the Aspirus Onbase Policy System please contact the IRB Office at (715) 847-2569 to acquire a supplemental CD of all applicable research policies and procedures for your review.

The purpose of this manual is intended as a guide for all who plan to carry out research, whether funded or not funded, involving the participation of human subjects. It provides basic information about what materials are needed to apply for human subjects approval and how to do it.

Pre-review your research protocol and consent form to identify potential issues and suggest ways to address them prior to IRB review

Provide educational information on the protection of human research subjects

Provide guidelines, interpretation of regulatory requirements and research protocol forms

Prepare needed documents, i.e., Certification of Assurances

Provide the forms and assistance to submit:

Changes to your research or consent form after research is approved

Progress reports for the IRB review to continue your research

Reports of unanticipated or adverse effects

The final report

FAQ

Q. What does the IRB consider research?
Research means a systematic investigation (including research development, testiing and evaluation) designed to contribute to generalizable knowledge.

Q. What do I need to do to conduct a research project?
Please review the Investigator Reference Manual, on the IRB website.

Q. Do I need IRB approval to send study data to an outside site?
Yes, you do need IRB approval to send study data to an outside site.

Q. Do I need IRB review/approval for Quality Improvement and/or Quality Assurance Activities?
Typically QI/QA efforts are NOT research. However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving quality of care, and in these cases the regulations for the protection of subjects in research (45 CFR part 46) may apply. To determine whether the regulations apply please contact the IRB office.

Q. What types of IRB review are there?
Types of IRB review include convened full board, expedited, and exempt review. All applications are submitted through IRBManager, the online electronic application submission system.

Q. What is the difference between Full Board, Expedited and Exempt Review?
Studies involving more than minimal risk*, including studies with vulnerable populations and/or sensitive questions, as well as studies with the possibility of physical risk and do not fit into any of the Exempt or Expedited categories (see below), will undergo convened Full Board review

Expedited review is for minimal risk* studies that fall under one of the specified categories listed in the IRB Expedited Review Standard Operating Procedure (SOP), which are also listed on the Initial IRB submission form. This review is conducted generally by one primary reviewer and typically is not does need to wait for review at the monthly convened Full Board IRB meeting. Protocols approved under Expedited review are however, subject to ongoing continuing reviews. That timeline is determined at the time of determination for approval.

Exempt review is for research studies that federal regulations have identified as those that can be exempt from IRB review. Research studies must be minimal risk and must fall under one of the specified categories. Most institutions, including Aspirus, require an IRB Administrative review to determine whether the claim for exemption is appropriate and whether exemption will be granted. Once exemption is granted, protocols are exempt form continuing IRB review unless it changes and no longer qualifies.

*Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Q. Does Expedited review mean that my protocol application gets processed faster?
No, Expedited review doesn't mean your protocol application is processed faster; rather instead of two or more reviewers and the full board, only one primary reviewer is assigned to review your protocol. However, most expedited protocol applications submitted are processed within a few weeks versus waiting for the full board IRB meeting, which meets once a month.

Q. How do I apply?
Contact the IRB Office at 715-847-2569 or ext. 72569 to acquire access to the on-line IRB application and various other forms for submission through the CYBERIRB electronic submission system.

Q. Which form should I use when requesting my research project be reviewed by the IRB?
Aspirus Wausau Hospital has transitioned into utilizing the internet to submit applications to the IRB through the use of a new program, "IRBManager". This program is accessible from any computer at any site through this website address link.

If you are a new Investigator or an investigator who has previously submitted a paper IRB submission form please contact the IRB Office 715-847-2569 to receive instructions, a USER ID and Password to access IRBManager.

All requests to the IRB for review should be submitted electronically through the IRBManager program.

Q. When does the IRB meet?
The AWH IRB meets on the 3rd Tuesday of every month. Please refer to the meeting dates tab above.

Q. What if I still have questions after reading the Investigator’s Manual?
You may contact the IRB Office using the information below:
Deb Block
IRB Coordinator-Human Research Protection and Compliance Program Manager
715-847-2569IRB@aspirus.org

Integrity- Treats others with dignity and respect. Honest, good character, dedicated to the ethical conduct of research and to protecting the rights and welfare of individuals who participate as subjects of research conducted at Aspirus.

Collaboration- Works well with others across the system to provide the best experience for all.

Who Qualifies

Selection Process

Nominations may be sent to the HRPC Manager throughout the year. The nominations will be reviewed by a small group (IRB Chair, IRB Coordinator, IRB Community Member, Institutional Official, and the Executive Director of Aspirus Health Foundation) following the October IRB meeting.

Award Presentation

The annual award will be presented to the recipient at the December IRB Meeting.

Award

Those honored will receive a plaque with recipient name and copy of nomination submission. They also will receive recognition on Aspirus IRB web site.

Dr. Charles Shabino receives the inaugural award that is named in his honor in December 2015.
Also pictured with Dr. Shabino is Deb Block, IRB Coordinator (left), and Lisa Opatik, IRB Chair.

Education

Human subject research investigators, co-investigators, research coordinators, research staff, and IRB members should complete appropriate education and training before reviewing or conducting human subject research. Documentation of such training must be submitted to the IRB prior to conducting human subject research. Furthermore, documentation of three (3) hours of continuing education or completion of a computer based training module regarding human subject research must be provided to the IRB on an annual basis.

Methods that may be used to obtain this continuing education will include:

Also if completing a computer-based training module, please submit a certification of completion (if available).

Some computer based training modules regarding human subject research are listed below:

http://phrp.nihtraining.com/users/login.php This free, web-based course from NIH Office of Extramural Research. Please note that this is a NEW course, with new content. This course replaced the previous Protecting Human Research Participants (PHRP) course as of March 1, 2008. To take the new course, please register by clicking on the Register button below presents information about the rights and welfare of human participants in research. The two-hour tutorial is designed for those involved in conducting research involving human participants. It satisfies the NIH human subjects training requirement for obtaining Federal Funds. You will have the option of printing a certificate of completion from your computer upon completing the course.

OHRP Educational Materials

OHRP has announced the availability of educational videos developed by the Division of Education and Development. These videos provide information on a variety of topics regarding the Department of Health and Human Services (HHS) regulations for the protection of human subjects of research described at 45 CFR part 46. Each video is approximately 20-25 minutes in length.

Research Use of Human Biological Specimens and Other Private Information

Mrs. Julie Kaneshiro, OHRP Policy Team Leader, is interviewed and discusses the challenges and complexities of the application of the HHS regulations at 45 CFR part 46 to activities involving biological specimens and other private information. Mrs. Kaneshiro discusses how to assess whether an activity constitutes non-exempt human subjects research. She clarifies when the HHS regulations do and do not apply to an activity and when an institution is engaged in human subjects research. This is an advanced topic video and is best suited to viewing by individuals already possessing a basic understanding of the HHS regulations for the protection of human subjects.

Reviewing and Reporting Unanticipated Problems and Adverse Events

Dr. Michael Carome, former OHRP Associate Director of Regulatory Affairs, is interviewed and discusses the criteria for determining if, in the context of human subjects research, an experience, incident, or outcome is an unanticipated problem involving risk to subjects or others, as described in the HHS regulations at 45 CFR part 46. He discusses the differences between adverse events and unanticipated problems and appropriate responses for investigators, IRBs, and institutions when encountering an unanticipated problem. He also discusses prompt reporting requirements and the difference between external and internal unanticipated problems, what to do in the case of multi-center research, and what information that should be reported to OHRP.

General Informed Consent Requirements

In this video, all of the characters are fictional. This presentation takes part in two scenes. In the first scene an investigator meets with the IRB Chair to go over some issues for obtaining legally effective informed consent from potential subjects with schizophrenia before submitting her protocol to the IRB. These issues include determining capacity to consent, using a legally authorized representative, and meeting the regulatory requirements for the process of informed consent. In the second scene, Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent.

Complex Issues with Research Involving Vulnerable Populations

When the video starts, you will see a fictional OHRP presenter summarizing the key points of the just completed presentation to the audience. She then invites questions from the audience, where she and her colleague (also a fictional OHRP presenter) respond to some rather complex and interesting questions regarding vulnerable populations.

Institutional Review Board (IRB) Membership

In this video, all of the characters are fictional. A Signatory Official, Dr. Quinn, meets with her staff members to discuss establishing an effective and efficient IRB for their institution. Ms. Hobbs, the future Human Subjects Protections Administrator, provides guidance regarding IRB membership, IRB guidance, quorum requirements, conflicts of interest, alternate members, the difference between recusals and abstentions, appointment of IRB members, written procedures, training, incentives and other relevant information for establishing and maintaining an IRB. As a dedicated investigator, Dr. Reznor provides relevant input and support to the discussion.

You must have the Real® Media player installed on your computer to view the training modules. Click the following link to Download the free Real® Media player. These videos are hosted on the NIH website.

Principles/Regulations/Policies

Principles

Regulations & Guidance

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have passed regulations regarding human subjects research (45 CFR Part 46 and 21 CFR Parts 50 and 56). DHHS, through its Office for Human Research Protections (OHRP), and the FDA also issue periodic guidance documents for institutions and investigators. Sections of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45 CFR Part 160 and Part 164 are also relevant to IRB review of research. Questions regarding the regulations or guidance documents may be directed to (715) 847-2569.

*Department of Health and Human Services Office for Human Research Protections (OHRP)

Use and Disclosure of Protected Health Information (PHI) for Research Purposes #6572

Corporate Ethics Policy - Conflict of Interest #2348

Corporate Signature Authority #6553

Federal-Wide Assurance (FWA)

Aspirus Wausau Hospital has negotiated a document with the Department of Health and Human Services in regard to the protection of human research subjects. This document, called a Federal-Wide Assurance (FWA), assures that all of our activities related to human subject research will be guided by the ethic principles in The Belmont Report and will comply with the procedural standards at 45 CFR 46. The FWA requires that we have a formal mechanism for monitoring compliance, and that we establish a continuing program to educate IRB members, IRB staff, and research investigators about human subject protection requirements. The FWA names Aspirus Wausau Hospital IRB as the IRB responsible for the review, approval, and ongoing monitoring of human subject research activities conducted at or by staff of Aspirus Clinics & Aspirus Wausau Hospital. A detailed list of the terms of the FWA can be found at Federalwide Assurance (FWA) for the Protection of Human Subjects. The FWA number is FWA00002047.